- Client: The client is the world’s largest medical technology and solutions provider with 8 business lines to address different health needs
- Industry Type: Medical devices
- Products and Services: Medical technology, services and solutions
- Geography: Global
The new EU MDR Regulation 2017, with newer and stricter regulations / rules, makes it challenging to register legacy products in the EU. The scope of this project was to perform a gap assessment on the new EU MDR and then remediate the gaps. Wipro was chosen to perform a gap assessment and remediation of more than 1,000 products from a large legacy product portfolio. These gaps were in several areas such as design, quality, risk management, labeling, clinical evaluation, and post market surveillance. Remediation activities included creation of design history files, position papers, justification memos, specification development, test method development, verification plans / protocols, testing, and validation.
The key challenges were:
- The EU Medical Device Directive will become a regulation by May 26, 2021.
- The customer had a large portfolio of products, which needed to comply with the new regulation within a short span of time. Some products classification would change to the higher risk classification due to the regulation.
- Some products needed to change material as they were deemed as carcinogenic, mutagenic and harmful for human reproduction. These products would have to undergo design validation testing.
Key aspects of the solution included:
- Interpret the regulation and come up with a strategy to provide evidence for technical documentation
- Evolve a checklist for technical documentation and use it to perform gap assessments
- Provide rationale for gaps and work with SMEs to close gaps
- Update or develop specifications, DHF and document attributes in document management system using change management process
- Wherever specifications are updated or newly developed - assess test methods, develop and validate if tests are unavailable
- Update hazardous substances list into product governance and compliance database
- Work with SMEs to initiate record change orders and data change orders
- The customer benefitted with reduction of more than 18,000 hours of effort put in by temporary team members and cost savings associated with these efforts which were predominantly onsite
- Fast ramp up with offshore support to achieve better time to market
- The customer’s principal engineers focused on day-to-day priorities. Wipro helped them free up their time for strategic initiatives
- 70 technical files representing more than 1,000 unique products were remediated in a very short time
- Saved more than $ 2M by outsourcing the project to Wipro